Module 3: Management of Patients on Antiretroviral Therapy

Unit 2: Initiation and Monitoring of ART in Adults

and Adolescents

Objectives

Explain the principles of successful antiretroviral therapy (ART)

Explain ART combinations that are used and the rationale for use of national standardized ART regimens

Explain drug and non-drug related considerations prior to initiating ART

Objectives Explain when ART should be initiated

and who should be started on ART Describe when to change or stop

ART Describe type of monitoring

employed in ART management

Goals of ART 1. Maximal suppression of HIV

replication 2. Restoration and preservation

of immune function 3. Improved Quality of Life 4. Reduction of HIV related

Morbidity and Mortality

1. Suppression of HIV Replication

ARVs must be taken in combination of at least 3 drugs

Strict adherence to treatment is of the upmost importance <95% adherence allows the rapid

development of viral resistance Poor adherers do badly

Fail treatment much earlier

Virological Failure and Adherence

Paterson,Swindells,Mohr. Adherence to PI therapy and outcomes in patients with HIV infection. Ann Intern Med 2000;133:21-30

>95% 82%90-95% 45%80-90% 33%70-80% 29%<70% 18%

Adherence with HAART Number with VL <500 cop/ml(% prescribed pills taken)

2. Immune Reconstitution

ART prevents CD4 destruction by HIV CD4 cell count can recover Improved function of CD4 cells CD4 cells are central to the immune

system So there is improved overall function of the

immune system It takes from 6 to 8 weeks for this to become

evident clinically

3. Improvement of QOL

Decreased hospitalizations Decreased risk of illnesses Increased general well-being Reversal of weight loss Ability to return to work

Take-home Messages about ART

Not an emergency treatment Benefits take 6 to 8 weeks Should not be initiated while an inpatient

Treat opportunistic infections first OI’s cause >90% of morbidity in HIV >90% of OI’s are simple to treat

ART is only one part of HIV Care All who require ART should first be on CPT

first Optimize nutrition

Take-home Messages about ART

Adherence counselling essential Patients should be able to demonstrate an

understanding of: Importance of strict adherence Their ability to afford drugs long term Life-long treatment, monthly follow-up

The Kenyan National Guidelines should be followed “If you don’t agree with them, campaign for a change rather than ignoring them!”

Rationale Behind Standardized ARV Therapy

Success of TB treatment program Simplicity of prescribing Preservation of certain ARV’s on a

population level Simple sequencing of 1st to 2nd line Increased efficiency in drug

procurement Cost and availability of FDC’s

Standard 1st Line Regime for Adults and Adolescents

Lamivudine+

Stavudine+

Nevirapine

Lamivudine+

Stavudine+

Efavirenz

or

Standard 2nd Line Regime

for Adults and Adolescents

Zidovudine+

Didanosine+

Lopinavir/Ritonavir

Zidovudine+

Didanosine+

Nelfinavir

or

For Patients on Non-standard 1st line Regimes…

1st LineD4T+ddI+NNRTI

AZT+3TC+ABC

AZT+3TC+PI

2nd LineAZT+3TC+LPV/r

NNRTI+LPV/r+d4T

NNRTI+ABC+ddI

A note on Fixed Dose Combinations (FDC’s)

WHO Approved FDC’s are available for: d4T/3TC/NVP D4T/3TC AZT/3TC

Advantages Decreased pill burden Increased adherence Mono or duo-therapy not possible Lower cost Simplify stock control and forcasting

GoK has chosen these for the National roll-out

When to Start ART in Adults and Adolescents

Where CD4 testing available

WHO II & III when CD4 < 200/mm3

WHO stage IV irrespective of CD4 level

When to Start ART in Adults and Adolescents

Where CD4 Testing Unavailable

WHO II when total lymphocyte count <1200/mm3

WHO III & IV regardless of total Lymphocyte count

Guidance on Clinical Criteria

CD4 levels are not “hard and fast” rules

A sick, deteriorating patient with a CD4 of 210 should not be excluded from ART if otherwise able and keen to begin

A very well, stable patient with a CD4 of 180 could reasonably opt for close follow up and deferral of ART to a later date

Pregnancy and ART Not a contraindication ART In general, best to defer to after the

first trimester (after organogenesis) EFV contraindicated ART greatly decreases vertical

transmission Also allows mother to remain well to

care for her child

Monitoring of ART (1)

ART is monitored using: Clinical information

Body Weight Signs and symptoms Past and present medical history Physical examination

End Points in Clinical Monitoring

Look for: Decrease or disappearance of

symptoms Increase in body weight Decrease in frequency and

severity of OIs

Monitoring of ART (2)

ART is monitored using: Laboratory Parameters

Minimum - HIV Test, Hb, pregnancy testStandard - FBC, SGPT/ALT, CreatinineDesirable - CD4Optional/Ideal - Viral Load

Schedule of Laboratory Monitoring

Test Baseline 1-2 months

6 month

s

12 months

18 months

24 months

CD4 X X1 X X1 XFBC X X X X X1 XCreatinine X X XPregnancy X X1 X1 X1 X1 X1

SGPT/ALT X X X X X XUrinalysis X X1 X1 X X1 X

X1: If clinically indicated